Job description

QA Auditor - Newark, DE

$40,000-$50,000

Summary
Incumbent will perform duties with integrity and ensure all QPS records and business affairs assigned to them are kept in a confidential manner (i.e., controlled, protected, and secured). Incumbent is responsible to audit and report each assignment to QPS management to ensure their client services conform to applicable Good Laboratory Practices and Guidance Documents (FDA, OECD Principles, Japanese MHLW).

Essential Functions
 Maintain client confidentiality and ensure that any QPS documents received for audit are controlled, protected and secured.
 Review final protocols/amendments for QPS" ability to interpret and perform the study with compliance.
 Review analytical procedures to the protocol and validated methods to ensure proper study conduct.
 Conduct assigned study inspection audits and audit records and personnel during study conduct.
 Audit equipment and laboratory records.
 Audit Employee Qualification Manuals.
 Review and process deviations and investigations.
 Audit study records and reports to ensure they accurately reflect the protocol/amendments, SOP(s), procedures and actual data results obtained during the study.
 Conduct facility walkthrough audits as assigned.
 Audit QPS SOP(s) to ensure contents meet regulatory requirements and interpretations.
 Provide compliance support to Operations (e.g., regulations, SOP(s), Good Documentation).
 Issue audit reports to disclose noncompliant findings to Principal Investigator, Study Director and Management and verify their follow-up responses are adequate and complete to close the audit.
 Send QPS audit reports, deviations and investigations to the non-QPS Study Director for documented review.
 Maintain organized and accurate audit files.
 Assist with client and government audits or any department goals as requested by supervisor or manager.

Education / Experience
 Advanced degree (Bachelor"s or Master"s), in Chemistry, Biochemistry, Pharmacology or related scientific discipline preferred AND
 Three years (3) working in a regulatory environment or position (GLP, GCP or GMP).

Supervisory Responsibility
This position has no direct or indirect supervisory responsibilities.

Work Environment
This job operates in a professional office environment. This role routinely uses standard office equipment such as computers, phones, photocopiers, filing cabinets and fax machines. Computers run on a Windows based operating system and proficiency with MS Office products, including Outlook, Word, Excel and PowerPoint, is required.

Physical Demands
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. This role is primarily sedentary, but the employee is occasionally required to traverse to other floors, offices, or sites to interact with colleagues or visitors, as well as to bend, stoop or reach to access filing and storage cabinets. The employee must frequently lift and/or move up to 10 pounds and occasionally lift and/or move up to 25 pounds. Specific vision abilities required by this job include close vision, distance vision, and ability to adjust focus.

***If interested and meet the requirements, please send your most up to date resume to:
Taylor Toy at ttyoy@synerfac.com

Knowledge / Skills / Abilities
 Ability to understand and comply with GLP regulations, principles and Guidance Documents.
 Ability to identify resources and use them to formulate solutions, make decisions and implement them.
 Ability to identify noncompliance and deviations and recommend corrective and preventative actions in an educational and persuasive manner.
 Ability to anticipate and identify critical issues or problems and recommend solutions.
 Ability to deal with conflict and drive resolution independently or through proper chain-of-command.
 Considers implications when making system-based recommendations and decisions.
 Demonstrates Life Sciences technical skills and the abilities necessary to achieve goals.
 Effective verbal and written communication skills.
 Proven ability to exercise good judgment and effectively balance work activities and changing priorities.

***If interested and meet the requirements, please send your most up to date resume to:
Taylor Toy at ttyoy@synerfac.com

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